Azerix 137 micrograms/50 micrograms/application nasal spray suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azerix 137 micrograms/50 micrograms/application nasal spray suspension

azelastine hydrochloride/fluticasone propionate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Azerix is and what it is used for

2. What you need to know before using Azerix

3. How to use Azerix

4. Possible side effects

5. Storage of Azerix

6. Contents of the pack and other information

1. What Azerix is and what it is used for

Azerix contains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine, which the body produces during an allergic reaction; thus, they reduce the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

This medicine is used to relieve symptoms of moderate to severe seasonal allergic rhinitis and perennial allergic rhinitis in adults and children 12 years of age and older, when treatment with either an antihistamine or intranasal corticosteroid alone is considered insufficient.

Seasonal or perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), house dust mites, molds, dust, or domestic animals.

This medicine relieves allergy symptoms such as rhinorrhea, postnasal drip, sneezing, nasal itching, or nasal congestion.

2. What you need to know before using Azerix

Do not use Azerix

• If you are allergic to azelastine hydrochloride or fluticasone propionate, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine if:

• You have recently undergone nasal surgery.
• You have a nasal infection. Infections of the nasal respiratory tract should be treated with antibacterial or antifungal agents. If you have been prescribed medication for a nasal infection, you may continue using this medicine to treat your allergy.
• You have tuberculosis or an untreated infection.
• You have vision changes or a history of increased intraocular pressure, glaucoma, and/or cataracts. If you have any of these conditions, you will be closely monitored during treatment with this medicine.
• You have impaired adrenal function. Caution is advised when switching from systemic steroid therapy to this medicine.
• You have severe liver disease. The risk of systemic adverse effects may be increased.

In these cases, your doctor will decide whether you can use this medicine.

It is important that you take the dose indicated in section 3 or as directed by your doctor. Treatment with doses higher than recommended for nasal corticosteroids may lead to adrenal suppression, which can cause weight loss, fatigue, muscle weakness, low blood sugar levels, salt cravings, joint pain, depression, and skin darkening. If you experience any of these adverse effects, your doctor may recommend alternative medication during periods of stress or elective surgery.

To avoid adrenal suppression, your doctor will advise you to take the lowest dose that effectively controls your rhinitis symptoms.

The use of nasal corticosteroids (such as this medicine) may cause slower growth in children and adolescents when used long-term. The doctor will regularly monitor children's growth and ensure they receive the lowest effective dose.

Contact your doctor if you experience blurred vision or other visual disturbances.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before using this medicine.

Children

This medicine is not recommended for use in children under 12 years of age.

Other medicines and Azerix

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of this medicine, so your doctor may wish to monitor you closely if you are taking these (including certain HIV medications: ritonavir, cobicistat, and antifungal treatments: ketoconazole).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine has minimal influence on the ability to drive and use machines.

Very rarely, you may experience fatigue or dizziness due to the underlying disease or during use of this medicine. In such cases, do not drive or operate machinery. Be aware that alcohol consumption may worsen these effects.

Azerix contains benzalkonium chloride

This medicine contains 14 micrograms (0.014 mg) of benzalkonium chloride per spray.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment. Inform your doctor or pharmacist if you experience discomfort while using the spray.

3. How to use Azerix

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

It is essential that this medicine is used regularly in order to achieve full therapeutic benefit.

Avoid contact with the eyes.

Adults and adolescents (12 years of age and older)

• The recommended dose is one spray into each nostril in the morning and one spray into each nostril in the evening.

Use in children under 12 years of age

• This medicine is not recommended for use in children under 12 years of age.

Use in case of renal and hepatic impairment

• No data are available in patients with renal or hepatic impairment.

Method of administration

Nasal route.

Read the following instructions carefully and use the product only as directed.

INSTRUCTIONS FOR USE

Preparing the spray

1. Gently shake the bottle for 5 seconds by tilting it up and down, then remove the protective cap (see Figure 1).

Figure 1

1. The first time the nasal spray is used, the pump must be primed by spraying into the air.
2. Prime the pump by placing two fingers on either side of the spray pump and placing your thumb on the base of the bottle.
3. Press and release the pump 6 times until a fine mist appears (see Figure 2).
4. The pump is now primed and ready for use.

Figure 2

1. If the nasal spray has not been used for more than 7 days, the pump must be re-primed by pressing and releasing it several times.

Spraying method

1. Gently shake the bottle for 5 seconds by tilting it up and down, then remove the protective cap (see Figure 1).
2. Blow your nose to clear the nasal passages.
3. Keep your head tilted forward, towards your feet. Do not tilt your head backwards.
4. Hold the bottle upright and carefully insert the spray nozzle into one nostril.
5. Close the other nostril with your finger, press the pump once quickly, and at the same time, gently inhale (see Figure 3).
6. Breathe through your mouth.

Figure 3

1. Repeat the procedure in the other nostril.
2. Breathe gently, and do not tilt your head backwards after administration. This prevents the medicine from reaching your throat and causing an unpleasant taste (see Figure 4).

Figure 4

1. After each use, clean the spray nozzle with a clean tissue or cloth, and replace the protective cap.
2. Do not pierce the nozzle if no spray is obtained. Clean the valve with water.

It is important that you use the dose prescribed by your doctor. Use only the amount recommended by your doctor.

Duration of treatment

This medicine is suitable for long-term use. The duration of treatment corresponds to the period during which you experience allergic symptoms.

If you use more Azerix than you should

If you apply more of this medicine in the nose, it is unlikely that you will experience any problems. If in doubt, or if you have used more than the recommended dose for a prolonged period, consult your doctor. If a person, especially a child, accidentally drinks this medicine, contact your doctor immediately or go to the nearest medical center.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Azerix

Use the nasal spray as soon as you remember, then take the next dose at your usual time. Do not use a double dose to make up for missed doses.

If you stop using Azerix

Do not stop treatment with this medicine without consulting your doctor, as this may compromise the success of your treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common adverse effects (may affect more than 1 in 10 people):

• Nasal bleeding.

Common adverse effects (may affect up to 1 in 10 people):

• Headache.
• Bitter taste in the mouth, especially if you tilt your head backwards during use of the nasal spray. This taste should disappear if you drink a soft drink a few minutes after using this medicine.
• Unpleasant odor.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Mild irritation inside the nose, which may cause slight stinging, itching, or sneezing.
• Nasal dryness, cough, dry throat, or throat irritation.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Dry mouth.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Dizziness or drowsiness.
• Cataracts, glaucoma, or increased eye pressure, possibly leading to vision loss and/or eye redness and pain. These adverse effects have been observed with prolonged treatment with fluticasone propionate nasal sprays.
• Skin and nasal mucosal lesions.
• Feeling of malaise, fatigue, exhaustion, or weakness.
• Rash, skin redness or itching, urticaria.
• Bronchospasm (narrowing of the airways in the lungs).

Seek immediate medical attention if you develop any of the following symptoms:

• Swelling of the face, lips, tongue, or throat, which may make swallowing or breathing difficult, and sudden appearance of a skin rash. These could be signs of a severe allergic reaction. Note that this is very rare.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Blurred vision.
• Nasal ulcers.

When this medicine is administered at high doses over a prolonged period, systemic adverse effects (adverse effects affecting the whole body) may occur. The likelihood of such effects is much lower when using a nasal corticosteroid spray compared to oral corticosteroids. These effects may vary between individual patients and among different corticosteroid preparations (see section 2).

Nasal corticosteroids may affect the normal production of hormones in your body, especially if high doses are used for a long time. In children and adolescents, this adverse effect may result in slower growth.

In rare cases, reduced bone density (osteoporosis) may occur when corticosteroids are administered via the nasal route over a long period of time.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azerix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label of the bottle and on the box after "EXP". The expiry date refers to the last day of the month indicated.

Do not refrigerate or freeze.

Expiry after first opening: Discard any remaining medicine 1 year after first opening the nasal spray.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azerix

The active substances are: azelastine hydrochloride and fluticasone propionate.

Each gram of suspension contains 1,000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

Each spray (0.14 g) delivers 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate (= 36 micrograms of fluticasone).

The other components (excipients) are: disodium edetate, glycerol, microcrystalline cellulose (E 460), sodium carboxymethylcellulose (E 466), polysorbate 80 (E 433), benzalkonium chloride (see section 2 “Azerix contains benzalkonium chloride”), phenylethyl alcohol, and purified water.

Nature of the product and contents of the container

This medicine is a homogeneous white suspension.

This medicine is supplied in a Type I amber glass bottle equipped with a spray pump, an applicator, and a protective cap.

The bottle contains 23 g of nasal spray suspension (providing at least 120 sprays).

This medicine is available in a 25 ml bottle containing 23 g of suspension or in a multipack containing 3 bottles, each with 23 g of suspension.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Especialidades Farmacéuticas Centrum, S.A.
C/ Sagitario, 14
03006 Alicante
Spain
Tel.: 965286700
Fax: 965286434
Email: [email protected]

Manufacturer

Kevaro Group Ltd
Ulitsa Tsaritsa Eleonora 9 Office 23, floor 5
1618 Sofia,
Bulgaria

Or

Adalvo Limited
Sir Temi Zammit Buildings
4 Malta Life Sciences Park Building 1 Level
San Gwann 3000
Malta

This medicine is authorized in the European Economic Area member states under the following names:

Finland: Azerix 137 mikrog. + 50 mikrog./annos, nenäsumute, suspensio
Spain: Azerix 137 microgramos/50 microgramos/aplicación suspensión para pulverización nasal

Date of the most recent revision of this leaflet: November 2024.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).